Powered Laser Surgical Instrument With MicrobeamFractional Output
ONG · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4810
Classification
FDA Product Code
ONG
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 878.4810
Review panel
SU
Medical specialty
General, Plastic Surgery
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
Definition
A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. The laser output is in form of tiny beams in micro range. Typically, indicated to be used in medical specialties of general and plastic surgery and of dermatology/aesthetic to destroy, remove or coagulate tissue, generally soft tissue. Indication for Use can be general and/or specific. The classification regulation 21 CFR 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light.